Industrial Engineer - Lean Manufacturing for Medical Devices

Pentamaster Corporation Berhad; Simpang Ampat; On-site; MYR 60,000 - 90,000; Full time

Job summary

Pentamaster Corporation Berhad in Malaysia is seeking an Industrial/ Manufacturing/ Mechanical or Mechatronic Engineer to drive process efficiency across plastics injection moulding, automated assembly and test equipment for medical device customers. You will optimize layouts, run time studies to lift OEE and productivity.

Degree in engineering; 2+ years in medical device/semiconductor/automation; knowledge of ISO 13485, FDA 21 CFR 820, cleanroom and validation.

Qualifications

• Degree in Industrial, Manufacturing, Mechanical or Mechatronic Engineering.
• 2+ years in medical device, semiconductor, or automation/ATE manufacturing preferred.
• Knowledge of ISO 13485; exposure to FDA 21 CFR 820, cleanroom and validation.

Responsibilities

• Optimize manufacturing processes, layouts, and line balancing.
• Run time & motion, capacity, and cycle-time studies to lift OEE and productivity.
• Support DFM/DFA reviews and process validation (IQ/OQ/PQ).
• Maintain PFMEA, control plans, work instructions, and routings.
• Apply Lean / Six Sigma and drive corrective actions (8D, CAPA).

Skills

Lean Six Sigma

OEE improvement

Line balancing

Education

Industrial/Manufacturing/Mechanical/Mechatronic Engineering degree

Job description

Pentamaster Corporation Berhad in Malaysia is seeking an Industrial/ Manufacturing/ Mechanical or Mechatronic Engineer to drive process efficiency across plastics injection moulding, automated assembly and test equipment for medical device customers. You will optimize layouts, run time studies to lift OEE and productivity.

Degree in engineering; 2+ years in medical device/semiconductor/automation; knowledge of ISO 13485, FDA 21 CFR 820, cleanroom and validation.